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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 21, 1999 - June 24, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
EC Number:
944-482-9
Molecular formula:
C13H20O
IUPAC Name:
Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 2613g; females: 2726 and 2581g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.

ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
TREATMENT:
The test substance was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test substance.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the guidelines at approximately 1, 24, 48 and 72 hours after administration. When present, corrosion of and/or staining of sclera and cornea by the test substance were recorded and reported.

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hrs.
Score:
0
Max. score:
4
Irritant / corrosive response data:
In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.
Other effects:
The body weights of all rabbits were considered to be within the normal range of variability.
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified.
Remarks:
According to Regulation (EC) No. 1272/2008 and its updates.
Conclusions:
In an eye irritation study with 3 rabbits, performed according to OECD 405 guideline and GLP principles, slight irritation was observed. All signs of irritation were reversible within 24 hours. The substance does also not need to be classified according to GHS



Executive summary:

The substance was tested for 4 hours in an eye irritation test in 3 rabbits according to OECD TG 405 test guideline and GLP principles.

In all animals, slight reddening of the conjunctivae as well as moderate watery discharge was observed and in one animal slight conjunctival swelling was observed, one hour after treatment. All signs of irritation were reversible within 24 hours.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Based on the results, the substance does not need to be classified for eye irritation according to Regulation (EC) No. 1272/2008 and its updates.